Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 4:53 PM
Study NCT ID:
NCT05943457
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin K2 Supplementation in Adult Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D014813', 'term': 'Vitamin K Deficiency'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D024482', 'term': 'Vitamin K 2'}, {'id': 'C062629', 'term': 'menaquinone 7'}], 'ancestors': [{'id': 'D014812', 'term': 'Vitamin K'}, {'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010836', 'term': 'Phytol'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients, investigators, and analysts will remain blind to the identity of the treatment from the time of randomization until the time of unblinding. The identity of the treatment will be concealed by using placebo pills that are identical in appearance, color, odor and packaging. Unblinding will only occur in the case of a medical emergency and at the conclusion of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Migraine subjects will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of monthly migraine days', 'timeFrame': '6 months', 'description': 'Effect of Vitamin K2 supplementation on the changes from baseline in monthly migraine days as compared to placebo. This will be assessed clinically using a questionnaire to be administered at the start, monthly, and at the end of the study (6 months) about frequency and number of migraine days per month.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in the headache impact score (HIT-6) as compared to placebo.', 'timeFrame': '6 months'}, {'measure': 'Changes from baseline in monthly severe migraine days.', 'timeFrame': '6 months', 'description': 'Changes from baseline in monthly severe migraine days as defined by a visual analogue scale rating above 7, as compared to placebo.'}, {'measure': 'Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.', 'timeFrame': '6 months'}, {'measure': 'Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.', 'timeFrame': '6 months'}, {'measure': 'Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo.', 'timeFrame': '6 months'}, {'measure': 'Changes from baseline of arterial stiffness level.', 'timeFrame': '6 months', 'description': 'Changes of arterial stiffness level assessed by measuring the cfPWV using Complior Analyze.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Arterial stiffness', 'Vitamin K deficiency', 'Migraine attack'], 'conditions': ['Migraine Headache', 'Arterial Stiffness', 'Vitamin K Deficiency']}, 'referencesModule': {'references': [{'pmid': '17381554', 'type': 'BACKGROUND', 'citation': 'Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.'}, {'pmid': '27247281', 'type': 'BACKGROUND', 'citation': 'Kurth T, Winter AC, Eliassen AH, Dushkes R, Mukamal KJ, Rimm EB, Willett WC, Manson JE, Rexrode KM. Migraine and risk of cardiovascular disease in women: prospective cohort study. BMJ. 2016 May 31;353:i2610. doi: 10.1136/bmj.i2610.'}, {'pmid': '28167849', 'type': 'BACKGROUND', 'citation': 'Mozos I, Stoian D, Luca CT. Crosstalk between Vitamins A, B12, D, K, C, and E Status and Arterial Stiffness. Dis Markers. 2017;2017:8784971. doi: 10.1155/2017/8784971. Epub 2017 Jan 12.'}, {'pmid': '22169620', 'type': 'BACKGROUND', 'citation': 'Westenfeld R, Krueger T, Schlieper G, Cranenburg EC, Magdeleyns EJ, Heidenreich S, Holzmann S, Vermeer C, Jahnen-Dechent W, Ketteler M, Floege J, Schurgers LJ. Effect of vitamin K2 supplementation on functional vitamin K deficiency in hemodialysis patients: a randomized trial. Am J Kidney Dis. 2012 Feb;59(2):186-95. doi: 10.1053/j.ajkd.2011.10.041. Epub 2011 Dec 9.'}, {'pmid': '28756183', 'type': 'BACKGROUND', 'citation': 'Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13.'}, {'pmid': '31769041', 'type': 'BACKGROUND', 'citation': 'Mansour AG, Ahdab R, Daaboul Y, Korjian S, Morrison DA, Hariri E, Salem M, El Khoury C, Riachi N, Aoun Bahous S. Vitamin K2 Status and Arterial Stiffness Among Untreated Migraine Patients: A Case-Control Study. Headache. 2020 Mar;60(3):589-599. doi: 10.1111/head.13715. Epub 2019 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or above\n* History of episodic migraine with or without aura since \\> 12 months according to the ICHD-3 criteria.\n* Migraine frequency from 4-14 days per month over the 3 months prior to screening.\n* Migraine frequency from 4-14 days per month during the baseline period of assessment.\n* Successful completion of the migraine diary during the baseline evaluation period.\n\nExclusion Criteria:\n\n* Migraine patients with superimposed tension type or other forms of primary headaches\n* Patients who are currently on any of the migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)\n* Patients who have been on any of the previously listed medications within 3 months of screening\n* Patient who takes the following medications:\n\n * Ergotamine or Triptans \\> 10 days per month\n * NSAIDs or paracetamol \\> 15 days per month\n * Opioids more than 4 days per month\n * Patients on anticoagulants\n* Other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia…)\n* History of hypersensitivity to the vitamin K2\n* History of soy protein, cheese, eggs and meat allergy\n* History of thrombotic events\n* Diagnosed coagulopathy or any condition related to coagulation\n* Cardiovascular event in the past month\n* Current or planned pregnancy\n* Lactation\n* Inability to tolerate oral medications\n* Known intestinal malabsorption or hypomotility syndromes\n* Atrial fibrillation\n* Active malignancy\n* Any acute illness in the past month'}, 'identificationModule': {'nctId': 'NCT05943457', 'acronym': 'ViKEM', 'briefTitle': 'Vitamin K2 Supplementation in Adult Episodic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Lebanese American University'}, 'officialTitle': 'Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine', 'orgStudyIdInfo': {'id': 'MK7-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (MK7) Arm', 'description': 'This corresponds to the sub-group of subjects who will receive the supplement (vitamin K2 or Menaquinone-7).', 'interventionNames': ['Dietary Supplement: Vitamin K2 or menaquinone-7']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'This corresponds to the sub-group of subjects who will receive placebo.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin K2 or menaquinone-7', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MenaQ7'], 'description': 'Vitamin K2 (MK7) 360 mcg/day orally once daily for 6 months', 'armGroupLabels': ['Intervention (MK7) Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo pills will be administered orally once daily for 6 months', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11-3288', 'city': 'Beirut', 'state': 'Beyrouth', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Sola Aoun Bahous, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'sola.bahous@lau.edu.lb', 'phone': '+9613259450'}], 'facility': 'Lebanese American University Medical Center - Rizk Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Sola Aoun Bahous, MD, PhD', 'role': 'CONTACT', 'email': 'sola.bahous@lau.edu.lb', 'phone': '+9613259450'}, {'name': 'Cedric Mhaseb, MD', 'role': 'CONTACT', 'email': 'cedric.mhasseb@lau.edu', 'phone': '+96176489620'}], 'overallOfficials': [{'name': 'Sola Aoun Bahous, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lebanese American University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'We have a plan to publish the study protocol as soon as possible.', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sola Aoun Bahous, M.D. Ph.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lesaffre International', 'class': 'INDUSTRY'}, {'name': 'Omicron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Sola Aoun Bahous, M.D. Ph.D.', 'investigatorAffiliation': 'Lebanese American University'}}}}